When managing EU MDR clinical evaluation enforcement scenarios, it is vital to properly understand the fundamental roles and responsibilities that the EU MDR assigns to affected economic operators.
Specifically, it is true that, pursuant to Article 10(8), the manufacturer shall ensure that the clinical evaluation report is permanently available to the authorised representative (AR) in order that the AR can fulfil the tasks assigned to it under the Article 11 mandate executed between the Manufacturer and AR. Yet when deliberating and setting the scope of the clinical evaluation tasks assigned to the AR within the mandate, remember two fundamentals established by the EU MDR:
- The obligations regarding clinical evaluation (and its proper execution) rest solely on the manufacturer, not the AR. These obligations may not in any way be delegated to the AR. Accordingly, if the AR asserts or prescribes how the clinical evaluation is to be documented, then that would tend to be inconsistent with the intent of the EU MDR.
- Per Annex VII.4.5.5 [clinical evaluation conformity assessment by the Notified Body (NB)], it is the NB (if any), not the AR, who holds the authority to examine, validate and verify that the Manufacturer's clinical evaluation adequately addresses the requirements of the EU MDR.
These regulatory boundaries are the basis for why the preferences of the Manufacturer and Notified Body (if any) generally take precedence over those of the AR. And it is the reason why an NB would typically indicate that it is up to the Manufacturer to determine and justify the Manufacturer's path regarding the way the clinical evaluation is reported.
That said, remember for practical intents and purposes that, pursuant to Article 11(5), the AR is legally liable for the manufacturer's defective devices on the same basis as, and jointly and severally with, the manufacturer. Consequently, it is not unreasonable or surprising that the AR would assert its preferences for how to unequivocally assure that the manufacturer's clinical evaluation complies with the EU MDR. For this reason, it is important that the Article 11 mandate between the Manufacturer and AR be carefully planned so that the operating terms set up regarding clinical evaluation reporting will be more likely to strike a proper balance between the Manufacturer's/NB's jurisdiction over the AR vs. the need to protect the AR against deficiencies in the Manufacture's clinical evaluation.
But remember also that the Article 11 mandate may be a contractual arrangement between the Manufacturer and AR. Consequently, be sure to closely review the terms of any existing mandate, as that could be legally binding for the parties thereto regardless of whether the mandate aligns with the intended parameters of the EU MDR. For example, if the mandate already obligates the Manufacturer to have separate clinical evaluation reports for the EU MDR vs. the MDD, then the Manufacturer would remain so obligated unless the parties mutually agree to revise the mandate.
In approaching this topic at the practical/implementational level of the clinical evaluation report, I know of no EU MDR requirement demanding that there be a separate clinical evaluation report for the EU MDR vs. the MDD. This means that the Manufacturer and AR have considerable liberty when addressing this topic. So in a scenario where the stakeholders are pondering separate clinical evaluation reports for the EU MDR and MDD, a sensible alternative would be to create a trace matrix within the clinical evaluation report itemizing and tracing the various requirements of the EU MDR to the particular page(s), narrative(s), data, etc., within the clinical evaluation report (or elsewhere) constituting the respective conformity. In so doing, be sure to include the following EU MDR clinical evaluation requirements in the trace matrix:
- Article 2 definitions 12, 44, 45, 48, 51, and 53;
- Article 5(3) [clinical evaluation prior to placing on the market and putting into service];
- Articles 10(3) and 10(9) [compliant clinical evaluation including PMCF (if any); quality management system attendance to clinical evaluation];
- Article 83(3) [updating the benefit-risk determination and clinical evaluation based on post-market surveillance];
- Article 61 in its entirety [of course];
- Annex II.6.1 [clear, organised, readily-searchable, unambiguous inclusion of the clinical evaluation report and updates in the technical documentation];
- Annex XIV Part A [of course]; and
- Annex XIV Part B [integration of PMCF (if any) with the clinical evaluation].
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 10-Nov-2020 21:40
From: Anonymous Member
Subject: CER Updates During MDR Transition Period
This message was posted by a user wishing to remain anonymous
Our company has been having some interesting discussion about how to handle our CERs during the period when we are transitioning from MDD to MDR.
We currently comply with MDD, so each CER cites the ERs for which the CER provides evidence of compliance, and includes other references to MDD requirements.
When we submit an MDR application for a product, of course we'll need to include an MDR-compliant CER, which means we'll need to switch to listing the relevant GSPRs rather than ERs and updating the references to MDR. We're assuming the MDR review and approval process may take 18–24 months, so we will need to continue with annual CER updates while the application is under review (our products are Class III).
We have proposed including information about both ERs and GSPRs in these transitional CERs, then switching to GSPRs-only post-approval, but our EUAR is insistent that we can't "mix" requirements of the directives and regulations within a single CER. This leaves us a bit puzzled about how to proceed. Our NB has indicated that it's up to us to determine and justify our path.
Can anyone offer guidance on how their companies are handling CERs during this transition period? I suspect this is a case where there isn't one correct answer, but hearing the experience of others would be very helpful. Thank you!